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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has Bladder Pain/Interstitial Cystitis Symptom Scale (BPIC-SS) total score of ≥19 and worst bladder pain/discomfort sub-score of ≥4 to ≤9
Diagnosis of IC/BPS or meets criteria for IC/BPS as defined by the American Urology Association
Must not have
Urinary tract infection (UTI) within the past 30 days, or history of recurrent UTI
Has current or history of clinically significant kidney disease or abnormal kidney function, or nephrolithiasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 2, 4, 6, 8, and 9
Summary
This trial will test if V117957 is safe and effective for treating interstitial cystitis/bladder pain syndrome when compared to a placebo.
Who is the study for?
This trial is for individuals with bladder pain syndrome, also known as interstitial cystitis. Participants should have symptoms like bladder pain and frequent urination. Specific eligibility details are not provided, but typically participants must meet certain health requirements and not be taking conflicting medications.
What is being tested?
The study is testing the effectiveness of a new medication called V117957 in relieving symptoms of bladder pain syndrome compared to a placebo (a substance with no active drug). The goal is to see if V117957 is safe, well-tolerated by patients, and better than taking nothing at all.
What are the potential side effects?
While specific side effects are not listed here, common ones for new bladder treatments may include digestive issues, potential allergic reactions, or skin irritation. The trial will monitor participants closely for any adverse effects that arise during the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bladder pain is severe, scoring 19 or more overall and between 4 to 9 at its worst.
Select...
I have been diagnosed with interstitial cystitis/bladder pain syndrome.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a urinary tract infection in the last 30 days or often get them.
Select...
I have a history of significant kidney problems or kidney stones.
Select...
I have blood in my urine due to bladder cancer or another serious condition.
Select...
I have had treatments for bladder issues, like injections or nerve stimulation.
Select...
I had surgery that affected how my bladder works.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 2, 4, 6, 8, and 9
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 2, 4, 6, 8, and 9
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline for bladder pain/discomfort scores over last 12 hours (morning and evening).
Secondary study objectives
Change from baseline in Bladder Pain / Interstitial Cystitis Symptom Score (BPIC-SS)
Change from baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI)
Change from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: V117957Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
V117957
2022
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
Imbrium TherapeuticsLead Sponsor
4 Previous Clinical Trials
405 Total Patients Enrolled
Purdue Pharma LPIndustry Sponsor
78 Previous Clinical Trials
15,724 Total Patients Enrolled
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